Zevin

Zevin Special Precautions

aciclovir

Manufacturer:

Biolab

Distributor:

Biopharm

Marketer:

Biopharm
Full Prescribing Info
Special Precautions
Thrombotic thrombocytopenic purpura/hemolytic uremic syndrome: Thrombotic thrombocytopenic purpura/hemolytic uremic syndrome, which has resulted in death, has occurred in immunocompromised patients receiving aciclovir therapy.
Renal effect: Renal failure, in some cases resulting in death, has been observed with aciclovir therapy.
Herpes zoster: There are no data on treatment initiated more than 72 hours after onset of the zoster rash. Advise patients to initiate treatment as soon as possible after a diagnosis of herpes zoster.
Genital herpes infection: Inform patients that aciclovir is not a cure for genital herpes. There are no data evaluating whether aciclovir will prevent transmission of infection to others. Because genital herpes is a sexually transmitted disease, advise patients to avoid contact with lesions or intercourse when lesions and/or symptoms are present to avoid infecting partners. Genital herpes can also be transmitted in the absence of symptoms through asymptomatic viral shedding. If medical management of a genital herpes recurrence is indicated, advise patients to initiate therapy at the first sign or symptom of an episode.
Chickenpox: Chickenpox in otherwise healthy children is usually a self-limited disease of mild to moderate severity. Adolescents and adult tend to have more severe disease. Treatment was initiated within 24 hours of typical chickenpox rash in the controlled studies, and there is no information regarding the effects of treatment begun later in the disease course.
Renal function impairment: Dosage adjustment is recommended when administering aciclovir to patients with renal impairment. Caution should also be exercised when administering aciclovir to patients receiving potentially nephrotoxicity agents because this may increase the risk of renal dysfunction.
Neurotoxicity: Neurotoxicity (eg, tremor/myoclonus, confusion, agitation, lethargy, hallucination and impaired consciousness) may be increased with higher doses and in patients with renal failure. Monitor patients for signs/symptoms of neurotoxicity; ensure appropriate dosage reductions in patients with renal impairment.
Varicella: For maximum benefit, treatment should begin within 24 hours of appearance of rash; oral route not recommended for routine use in otherwise healthy children with varicella but may be effective in patients at increased risk of moderate to severe infection (>12 years of age, chronic cutaneous or pulmonary disorders, long-term salicylate therapy, corticosteroid therapy).
Potentially significant drug-drug interaction may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy.
Use in the Elderly: The duration of pain after healing was longer in patients 65 years and older. Nausea, vomiting and dizziness were reported more frequently in elderly subjects. Elderly patients are more likely to have reduced renal function and require dose reduction. Elderly patients are also more likely to have renal or CNS adverse events. With respect to CNS adverse events observed during clinical practice, somnolence, hallucinations, confusion, and coma were reported more frequently in elderly patients.
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